Over the last two decades, the commercialization of silicone-hydrogel ("SiHy") composite technologies has led to new soft CLs that are more breathable, comfortable, and affordable, including in daily disposable versions which have considerably broadened the customer base, especially among younger generations. Despite these improvements, the major persistent problem facing contact lenses is their poor compatibility with ocular environment, particularly the tear film. While the softness of the new composite materials made lenses more comfortable by conforming better to the cornea, the resultant tight fitting considerably lowers the tear exchange rate in the post-lens tear film. In addition, the precision of lens design and fabrication, limited by the difficulties of the thermal expansion of a dual-domain (silicon and hydrogel) substrate, are adequate only for adjusting an image's focus, not its visual acuity caused by other higher- order optical aberrations. We propose to solve these issues by creating a novel contact lens material that will lead to a new best-in-class soft lens with significant improvements in vision correction, clarity and comfort, and wide applicability to numerous patient populations. This project will engineer the new generation of lens innovations based on several recent advances in material and fabrication nanotechnologies. The combined application of submicron morphology control, molecular self-assembly, and high-precision molding (as well as 3-D printing), will make future CL devices more precise, biocompatible, and versatile. We identified three major areas of improvement in CLs that will benefit from our implementation of such new emerging technologies: (a) Pre-synthesis of new silicone block-copolymers for higher-precision control of domain morphology during lens fabrication, (b) Application of high-precision fabrication and high-definition ("HD") design for correcting the spherical aberration of CLs, and (c) Engineering a novel design of lens material and surface coating for enhancing PLTF turnover to improve ocular health. The new product would widely replace current CLs for at least the 39 million patients in the US market, and likely expand this market significantly with new and valuable functions such as control of myopia progression for adolescents and night vision enhancements for the elderly (by high-precision control and high-definition design), as well as unprecedented comfort and biocompatibility (by new surface coating's enhancement of PLTF turnover). Further, the new level of comfort and extended wear time would solve one key challenge associated with current state-of-the-art in ocular drug delivery and monitoring devices, promoting our technology to a future platform for growing these applications to treat other large populations such as the 64 million glaucoma patients worldwide.
Public Health Relevance Statement: PROJECT NARRATIVE Soft contact lenses are an $11 billion commercial market and worn by 39 million people in the U.S. (20% increase from 2000). In addition to limitations in design precision that affect visual clarity of the lens, a major related health problem is lens biocompatibility, which can lead to numerous patient complications and discomfort, including notably acanthamoeba keratitis ($175 million healthcare costs per year in the U.S.). We propose to solve this problem by developing an advanced silicone hydrogel (SiHy) contact lens with novel tear exchange mechanism and better visual precision, fully compatible with the ocular environment. This new generation of materials will allow for extended wear times beyond the current accepted modalities (1-2 week, monthly), and create new opportunities for corrective functions (e.g., night vision enhancement, myopia progression control), as well as a future platform for commercially viable ocular health monitoring and drug delivery lenses.
Project Terms: 3-Dimensional; Acanthamoeba Keratitis; Address; Adolescent; Adverse effects; Affect; antimicrobial drug; Appearance; Area; Astigmatism; base; Biocompatible; Biocompatible Coated Materials; biomaterial compatibility; Blood capillaries; capillary; Clinical Research; commercialization; Complex; Contact Lenses; Convection; copolymer; Cornea; Corneal Topography; Cosmetics; cost; design; Devices; Dimensions; Drug Delivery Systems; Drug Monitoring; Dryness; Elderly; Emerging Technologies; Engineering; Environment; Eyeglasses; Film; Future; Gases; Generations; Glaucoma; Goals; Growth Factor; Health; Health Care Costs; Hormones; Hydrogels; Hydrophilic Contact Lenses; Hydrophobicity; Hyperopia; Hypoxia; Image; improved; Infection; Inflammation; innovation; Laser In Situ Keratomileusis; Lead; lens; Marketing; Measurable; Measures; Medical Device; Methods; Modality; Molds; molecular assembly/self assembly; Molecular Conformation; Monitor; monitoring device; Morphology; Myopia; Nanotechnology; Needles; novel; Nutrient; Operative Surgical Procedures; Optics; Optometry; Oxygen; patient population; Patients; Peptides; Performance; Permeability; Phase; Photorefractive Keratectomy; Polynomial Models; Population; Presbyopia; Printing; Problem Solving; Process; Production; Property; prototype; Redness; Risk; Shapes; Silicon; Silicones; Structure; submicron; Surface; surface coating; Surface Tension; surfactant; Technology; Time; Vision; Visual; Visual Acuity; Visual impairment; wasting; Water
